Associate Clinical Pbpk Modeler, Clinical

hace 1 semana

Barcelona, España AstraZeneca A tiempo completo

**Typical Accountabilities**
- Utilize physiologically-based pharmacokinetic (PBPK) and translational modeling tools to enable clinical PK projections for drug-drug interactions (DDIs), pediatric and other specific populations, and other clinical development questions
- Collaborate with Drug Metabolism and Pharmacokinetic (DMPK) Scientists and Clinical Pharmacology scientists to generate these mechanistic models
- Validate the mechanistic models to the level of being able to be used in Regulatory submissions and to influence the design of clinical trials
- Communicate clearly and effectively both internally and externally on topics related to PBPK clinical DDI and pediatric and other specific populations predictions
- Keep up to date with emerging literature, modeling science, and regulatory expectations

**Education, Qualifications, Skills and Experience**
- Knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)
- Demonstrated broad translational development expertise and experience exemplified by 0-4 Years of drug development experience, with emphasis on PBPK modelling
- Good knowledge in pharmacology, drug targets and core disease areas
- Demonstrated ability to identify, develop and execute PBPK activities at a project level
- Good oral and written communication skills
- Good knowledge of global regulatory, compliance, processes, standards and issues specific to PBPK
- PhD degree with relevant experience required
- Relevant regulatory experience (written)
- Training and experience with PBPK and other relevant software (e.g., SimCYP, GastroPlus, PK-Sim, Phoenix WinNonlin)
- Fluency in spoken and written English language

  • Clinical Research Associate Ii

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Clinical Research Associate II** **-** **(**22003353**)** **Description** **Clinical Research Associate II, Spain** Remote **Who We Are** Synteract®, a Syneos Health® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We...

  • Clinical Research Associate Ii

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Research Associate II, Spain** Remote **Who We Are** Synteract®, a Syneos Health® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering...

  • Clinical Trial Ambassador

    hace 24 horas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Overview** The Clinical Trial Ambassador will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice as it relates to areas of interest. This position interacts with various internal and external stakeholders, with a focus on...

  • Clinical Trial Manager Ii

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II - Senior Clinical Trial Manager - Sponsor Dedicated** **Oncology experience is essential** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts...

  • Clinical Research Associate

    hace 4 semanas

    Barcelona, España JCW Group A tiempo completo

    Clinical Study Associate Manager (Contract) – Digital / Remote Patient Monitoring Spain - Barcelona ⏱ Start: Jan/Feb Contract: Long-term program support (6-12 months) Industry: Neurology / Digital Clinical Trials We are looking for several experienced Clinical Study Associate Managers to support ongoing neurology-focused clinical studies involving...

  • Clinical Research Associate

    hace 4 semanas

    Barcelona, España JCW Group A tiempo completo

    Clinical Study Associate Manager (Contract) – Digital / Remote Patient MonitoringSpain - Barcelona ⏱ Start: Jan/FebContract: Long-term program support (6-12 months)Industry: Neurology / Digital Clinical TrialsWe are looking for several experienced Clinical Study Associate Managers to support ongoing neurology-focused clinical studies involving digital...

  • Clinical Research Associate

    hace 2 semanas

    Barcelona, España JCW Group A tiempo completo

    Clinical Study Associate Manager (Contract) – Digital / Remote Patient Monitoring Spain - Barcelona Start: Jan/Feb Contract: Long-term program support (6-12 months) Industry: Neurology / Digital Clinical Trials Inscríbase (haciendo clic en el botón correspondiente) después de revisar toda la información relacionada con el trabajo a continuación.We are...

  • Clinical Research Associate

    hace 2 semanas

    barcelona, España JCW Group A tiempo completo

    Clinical Study Associate Manager (Contract) – Digital / Remote Patient Monitoring Spain - Barcelona ⏱ Start : Jan / Feb Contract : Long-term program support (6-12 months) Industry : Neurology / Digital Clinical Trials We are looking for several experienced Clinical Study Associate Managers to support ongoing neurology-focused clinical studies involving...

  • Clinical Trial Manager

    hace 2 semanas

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **JOB SUMMARY** **The Clinical Trial Manager serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). May be regional lead based on size and complexity of project, or support lead under mentoring or supervision of an experienced CTM. The position as defined by scope...

  • Principal Clinical Data Scientist

    hace 6 días

    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Principal Clinical Data Scientist** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...